BGB-43395 / BeOne Medicines - LARVOL DELTA

KANDELA-302: A Phase 3, Global, Open-Label, Randomized Study of the Selective CDK4 Inhibitor BGB-43395 + Letrozole vs CDK4/6 Inhibitors (CDK4/6i) + Letrozole for First-Line (1L) Treatment (Tx) of Advanced or Metastatic HR+/HER2− Breast Cancer (BC) (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: BeOne Medicines

New P1 trial

BGB-43395-101: BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=433 | Recruiting | Sponsor: BeOne Medicines | Trial completion date: Nov 2028 ➔ Dec 2029 | Trial primary completion date: Nov 2028 ➔ Dec 2029

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

BGB-43395 (CDK4 inhibitor): Initiated Phase 3 study in combination with letrozole for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer. (Businesswire)

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=79 | Not yet recruiting | Sponsor: BeiGene | Phase classification: P1a/1b ➔ P1

Phase classification • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=399 | Recruiting | Sponsor: BeOne Medicines | N=300 ➔ 399 | Trial completion date: Jun 2028 ➔ Nov 2028 | Trial primary completion date: Jun 2028 ➔ Nov 2028

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=79 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: BeiGene | N=79 ➔ 300 | Trial completion date: May 2026 ➔ Jun 2028 | Trial primary completion date: May 2026 ➔ Jun 2028

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

BGB-43395-102: BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: BeOne Medicines | Active, not recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Apr 2026

Trial completion • Trial completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2

First disclosure of frontline treatment (1L tx) with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer (BC): A phase 1 safety expansion. (ASCO 2026) - P1 | "The CDK4-selective inhibitor BGB-43395, in combination with letrozole, demonstrated a favorable safety profile, with low hematologic and manageable gastrointestinal toxicity. Antitumor activity in 1L tx of pts with advanced HR+/HER2− BC was promising. Doses of 400 mg and 240 mg BID demonstrated efficacy and safety that support further development in combination with letrozole."

Clinical • Combination therapy • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CDK6 • CDKN2A • HER-2

BG-68501-101: A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors (clinicaltrials.gov) - P1 | N=103 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | N=258 ➔ 103 | Trial completion date: Jul 2028 ➔ Aug 2026 | Trial primary completion date: Apr 2028 ➔ Aug 2026

Enrollment change • Enrollment closed • First-in-human • Platinum resistant • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • CDK2 • HER-2

CDK4 Program Advances in Breast Cancer (TradingView) - "BGB-43395 plus letrozole produced confirmed objective response rates of 68.4% at 240 mg and 63.2% at 400 mg...A randomized Phase 3 trial, known as KANDELA-302, had randomized its first patient...The trial is expected to enroll approximately 1,056 patients and compare BGB-43395 plus letrozole with a standard CDK4/6 inhibitor plus letrozole."

P1 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

…Oral presentations at ASCO highlight rapid acceleration of BeOne’s solid tumor pipeline (Businesswire) - "Key data presentations across our solid tumor programs include: (i) First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer; (ii) Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data; (iii) Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody, with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients."

P1 data • Hepatocellular Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (clinicaltrials.gov) - P3 | N=1056 | Recruiting | Sponsor: BeOne Medicines | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

First Quarter 2026 Business Highlights: Select Clinical-Stage Programs (Businesswire) - "Hematology: BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation. Breast and Gynecological Cancers: BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO. BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO."

P1 data • Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Marginal Zone Lymphoma • Solid Tumor

A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: BeOne Medicines | Trial completion date: Mar 2029 ➔ Nov 2028 | Trial primary completion date: Mar 2029 ➔ Nov 2028

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CDK2

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (clinicaltrials.gov) - P3 | N=1056 | Not yet recruiting | Sponsor: BeOne Medicines

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Anticipated R&D Milestones (Businesswire) - "BGB-43395 (CDK4 inhibitor): Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer: 1H 2026...BGB-B2033 (GPC3x41BB bispecific antibody): Potentially registrational Phase 2 trial initiation: 2H 2026."

New P2 trial • New P3 trial • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: BeOne Medicines | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Trial in progress: a phase 1 dose-escalation study evaluating BGB-21447 (BCL2 inhibitor) in combination with fulvestrant with and without BGB-43395 (CDK4 inhibitor) in patients with previously treated HR+/HER2− metastatic breast cancer (SABCS 2025) - P1 | "Patients with prior BCL2i exposure are excluded.Primary objectives are to assess the safety and tolerability of BGB-21447 in combination with fulvestrant, with or without BGB-43395, and to determine the maximum tolerated dose, maximum administered dose, and recommended dose for expansion of both the doublet and triplet combination. Secondary objectives are preliminary antitumor activity (objective response rate, duration of response, and time to response per Response Evaluation Criteria in Solid Tumors v1.1), characterization of the PK (single dose and steady state), and the preliminary effect of food on PK.This study is currently recruiting patients, with sites open across Australia, China, and the United States (Part A only)."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • BCL2L1 • CDKN2A • ER • HER-2

A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Not yet recruiting | Sponsor: BeOne Medicines

New P1 trial • Oncology • Solid Tumor

BG-68501-101: A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors (clinicaltrials.gov) - P1 | N=258 | Recruiting | Sponsor: BeiGene | Trial completion date: Feb 2028 ➔ Jul 2028

Platinum resistant • Trial completion date • Bladder Cancer • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: BeiGene | N=92 ➔ 120

Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BCL2

BGB-43395-103: A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ May 2025 | Trial primary completion date: Nov 2025 ➔ May 2025

Trial completion • Trial completion date • Trial primary completion date

BGB-43395-103: A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Nov 2025 | Trial primary completion date: May 2025 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date